Travel MedicineNCT02625129
Effectiveness of and Satisfaction With a Pharmacist-managed Travel Medicine Clinic
An observational study of Travel Medicine, run by University of Waterloo at 1 site in Canada.
Trial summary
This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Travel Medicine
- What is being tested?
- Pharmacist-provided travel care
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of individuals presenting for travel consultations at the Travel Health Network. No restrictions will be placed related to patient demographics, destinations, or travel itineraries; however, travellers with an expected return date after September 1, 2016 will be excluded, to ensure complete follow-up and data analysis within the proposed project time frame. A convenience sample of 100 patients will be consecutively enrolled .
Who may be able to join
- Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada
Who cannot join
- Travellers with an expected return date after September 1, 2016
- Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Clinical Effectiveness and Patient Satisfaction of a Pharmacist-managed Travel Medicine Clinic Under an Expanded Scope of Practice
This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations.
Read the detailed description
The study will be conducted at the Travel Health Network, a full-service travel medicine clinic located in St. Albert, Alberta. Care will be provided by a pharmacist with a specialized practice in travel medicine, authorization to prescribe vaccines and prescription drugs, and authorization to administer vaccines by injection.
The study will be a prospective mixed-methods cohort study, describing patients receiving care from a pharmacist-managed travel medicine clinic and their travel health needs, and evaluating their adherence to recommended vaccines and oral therapies, satisfaction with the care provided, and their health status and management of health issues arising while travelling. Chart reviews will elicit descriptive quantitative data related to patients' travel medicine needs and adherence to recommended vaccinations and oral pharmacotherapy, followed by surveys containing open-ended qualitative questions to elicit overall patient satisfaction and the management of any health issues encountered during travel. Due to the nature of the study involving patients presenting to the clinic for a consultation, neither a control group nor blinding is possible.
A convenience sample of 100 subjects will be enrolled.
- Conditions
- Travel Medicine
- Being tested
- Pharmacist-provided travel care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-provided travel careOther
Subjects will receive a pre-travel consultation from a pharmacist with specialty training in travel medicine, and with authorization to prescribe medications and vaccines and administer injections
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-provided travel care | Not described Receives: Other: Pharmacist-provided travel care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of recommended pre-travel vaccinations administered before departure according to chart review
From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.
Measured: Up to 7 months.
The proportion of recommended pre-travel oral pharmacotherapies dispensed before departure by a community pharmacy according to electronic health record
From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.
Measured: Up to 7 months.
Secondary outcomes (4)
Average satisfaction (along 1-5 scale) with care provided elicited through an online survey post-travel
Measured: 1 week following return from travel according to participant's planned itinerary
Frequency of reason(s) for declining any recommended vaccines or medications according to participant self-report through an online survey
Response options: didn't feel I was at risk, cost, concern about vaccine ingredients or safety, other (specify)
Measured: 1 week following return from travel according to participant's planned itinerary
Number of reports of any health issues over the course of travel according to participant self-report through an online survey
Response options: Traveller's diarrhea, Altitude sickness, Malaria, Fever (Dengue, Chikungunya), Respiratory illness, Other (specify)
Measured: 1 week following return from travel according to participant's planned itinerary
Frequency of management strategies of any health issues over the course of travel according to participant self-report through an online survey
Response options: Nothing - it went away on its own, Took a non-prescription medication I had purchased before departure, Took a non-prescription medication I purchased while travelling, Called or emailed the Travel Health Network for advice, Searched the internet for guidance on how to manage it, Saw a physician while travelling, Saw a physician upon returning home, Other (specify)
Measured: 1 week following return from travel according to participant's planned itinerary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travel MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, Travel Health Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625129
- Sponsor's protocol ID
- 21080
- Status last verified
- Jan 2018
- First submitted
- 25 Nov 2015
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Clinical Effectiveness and Patient Satisfaction of a Pharmacist-managed Travel Medicine Clinic Under an Expanded Scope of Practice
- ClinicalTrials.gov ID
- NCT02625129
- Acronym / sponsor ID
- 21080
- Conditions
- Travel Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, Travel Health Network
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations.
Detailed description
The study will be conducted at the Travel Health Network, a full-service travel medicine clinic located in St. Albert, Alberta. Care will be provided by a pharmacist with a specialized practice in travel medicine, authorization to prescribe vaccines and prescription drugs, and authorization to administer vaccines by injection.
The study will be a prospective mixed-methods cohort study, describing patients receiving care from a pharmacist-managed travel medicine clinic and their travel health needs, and evaluating their adherence to recommended vaccines and oral therapies, satisfaction with the care provided, and their health status and management of health issues arising while travelling. Chart reviews will elicit descriptive quantitative data related to patients' travel medicine needs and adherence to recommended vaccinations and oral pharmacotherapy, followed by surveys containing open-ended qualitative questions to elicit overall patient satisfaction and the management of any health issues encountered during travel. Due to the nature of the study involving patients presenting to the clinic for a consultation, neither a control group nor blinding is possible.
A convenience sample of 100 subjects will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-provided travel care | – | Other: Pharmacist-provided travel care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals presenting for travel consultations at the Travel Health Network. No restrictions will be placed related to patient demographics, destinations, or travel itineraries; however, travellers with an expected return date after September 1, 2016 will be excluded, to ensure complete follow-up and data analysis within the proposed project time frame. A convenience sample of 100 patients will be consecutively enrolled .
Key inclusion criteria (1 listed)
- Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada
Key exclusion criteria (2 listed)
- Travellers with an expected return date after September 1, 2016
- Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-provided travel careSubjects will receive a pre-travel consultation from a pharmacist with specialty training in travel medicine, and with authorization to prescribe medications and vaccines and administer injections | Other | Pharmacist-provided travel care |
Primary outcome
The proportion of recommended pre-travel vaccinations administered before departure according to chart review
Time frame: Up to 7 months.
From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.
The proportion of recommended pre-travel oral pharmacotherapies dispensed before departure by a community pharmacy according to electronic health record
Time frame: Up to 7 months.
From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.
4 secondary outcomes
Average satisfaction (along 1-5 scale) with care provided elicited through an online survey post-travel
Time frame: 1 week following return from travel according to participant's planned itinerary
Frequency of reason(s) for declining any recommended vaccines or medications according to participant self-report through an online survey
Time frame: 1 week following return from travel according to participant's planned itinerary
Number of reports of any health issues over the course of travel according to participant self-report through an online survey
Time frame: 1 week following return from travel according to participant's planned itinerary
Frequency of management strategies of any health issues over the course of travel according to participant self-report through an online survey
Time frame: 1 week following return from travel according to participant's planned itinerary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Travel Medicine, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of recommended pre-travel vaccinations administered before departure according to chart review (time frame: Up to 7 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.